Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127673
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2005-08-05
Brief Title:
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Effectiveness of PTSD Treatment CBT Versus Sertraline
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder
Detailed Description:
Exposure to traumatic events such as automobile accidents and assault can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder PTSD PTSD is an anxiety disorder characterized by avoidance hyperarousal symptoms and mental re-experiencing of the traumatic event PTSD is a serious condition that may cause social and psychological impairment therefore safe and effective treatments are needed Both CBT and antidepressant therapy have been shown to effectively treat PTSD symptoms however comparisons of the treatments are limited This study will compare the short- and long-term effectiveness of CBT and the antidepressant sertraline
Participants will either be randomly assigned to CBT or sertraline or they will be able to choose one of the two treatments which will be given for 10 weeks followed by 24 months of follow-up assessments Participants in the CBT group will have 10 weekly sessions of therapy During the therapy sessions participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling Participants will also be encouraged to practice the techniques learned in therapy in everyday life Participants in the antidepressant group will take sertraline daily for 10 weeks These participants will be seen weekly by a psychiatrist who will offer general encouragement and support monitor response to medication and record any side effects participants may be experiencing The medication may be adjusted according to a dosing schedule and based on the study doctors judgment At the end of 10 weeks participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months Participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks Self-report scales and questionnaires will be used to assess participants PTSD symptoms depression anxiety and social functioning These assessments will occur at 3 6 12 and 24 months after the study treatment period
Participants will either be randomly assigned to CBT or sertraline or they will be able to choose one of the two treatments which will be given for 10 weeks followed by 24 months of follow-up assessments Participants in the CBT group will have 10 weekly sessions of therapy During the therapy sessions participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling Participants will also be encouraged to practice the techniques learned in therapy in everyday life Participants in the antidepressant group will take sertraline daily for 10 weeks These participants will be seen weekly by a psychiatrist who will offer general encouragement and support monitor response to medication and record any side effects participants may be experiencing The medication may be adjusted according to a dosing schedule and based on the study doctors judgment At the end of 10 weeks participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months Participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks Self-report scales and questionnaires will be used to assess participants PTSD symptoms depression anxiety and social functioning These assessments will occur at 3 6 12 and 24 months after the study treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH066348 | NIH | None | httpsreporternihgovquickSearchR01MH066348 |